| Assembly for controlling emptying of a female urine bladder, incontinence valve, and urine drainage assembly comprising the assembly -> Monitor Keywords |
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  Assembly for controlling emptying of a female urine bladder, incontinence valve, and urine drainage assembly comprising the assemblyUSPTO Application #: 20070073414Title: Assembly for controlling emptying of a female urine bladder, incontinence valve, and urine drainage assembly comprising the assembly Abstract: An assembly for controlling emptying of a urine bladder, adapted to be positioned into a urethra of a female is disclosed. It comprises an oblong and substantially cylindrically shaped body to be inserted into the urethra, the body presenting a urine inlet and a urine outlet, at the ends of the body, connected by a through hole extending through the body substantially in the longitudinal direction of the body, the body presenting a length being shorter than the length of the urethra, causing the bladder neck to block the body from being in contact with the urine in the bladder when positioned in the urethra, the body presenting a length being longer than a cross section of the body, the through hole being able to receive a urine conducting member, which is projectable through the urine inlet to enter the bladder, a holder mounted to an outer surface of the body, and a plate limiting the movement in the longitudinal direction towards the urine inlet and fixed at the urine outlet, the plate presenting a larger cross section than the body. An incontinence valve, and a urine drainage assembly comprising the assembly are also disclosed. (end of abstract) Agent: Gauthier & Connors LLP Suite 2300 - Boston, MA, US Inventor: Patrik Westerkull USPTO Applicaton #: 20070073414 - Class: 623023660 (USPTO) Related Patent Categories: Prosthesis (i.e., Artificial Body Members), Parts Thereof, Or Aids And Accessories Therefor, Implantable Prosthesis, Hollow Or Tubular Part Or Organ (e.g., Bladder, Urethra, Bronchi, Bile Duct, Etc.), Urethra The Patent Description & Claims data below is from USPTO Patent Application 20070073414. Brief Patent Description - Full Patent Description - Patent Application Claims
TECHNICAL FIELD [0001] A first aspect of the present invention relates to an assembly for controlling emptying of a urine bladder. [0002] A second aspect of the present invention relates to an incontinence valve comprising the assembly of the first aspect. [0003] A third aspect of the present invention relates to a urine drainage assembly comprising the assembly of the first aspect. BACKGROUND OF INVENTION [0004] The use of intra urethral incontinence valves represents an important treatment for female patients having incontinence problems. For severe incontinence the alternative is mayor surgery with significant risks and uncertain outcome. An intra urethral incontinence valve is therefore a treatment option where the patient can become independent of large size pads. Intra urethral incontinence valves are described in U.S. Pat. No. 3,812,841, WO 99/08629, U.S. Pat. No. 5,030,199 and U.S. Pat. No. 6,105,580. [0005] A mayor challenge for intra urethral incontinence valves is the problem with blockage due to encrustations and formation of bladder stones on the surface of the portion of the device that is in the bladder and in direct contact with the urine most of the time. It is important that these devices offer a complete emptying of the bladder since residual urine In the bladder is a well-known cause for urinary tract infections. Therefore the design in both WO 99/08629 and U.S. Pat. No. 5,030,199 includes a valve member reaching all the way from the bladder to the opening of the urethra. These designs offer complete emptying of the bladder but on the other hand they involve a significant risk of encrustations on the foreign body constantly seated in the bladder. In both U.S. Pat. No. 3,812,841 and U.S. Pat. No. 6,105,580 a design for a male urethra is described. These designs however do present limitations since there is a significant risk of incomplete emptying of the bladder and urinary tract infections, especially, this would be the case if such a design would be used for the female urethra being much shorter than the male urethra. In spite of several efforts since U.S. Pat. No. 3,812,841 was filed in 1972, incomplete emptying of the bladder, encrustations and urinary tract infections are still unsolved challenges with these devices. [0006] The use of indwelling catheters also called Foley catheters used for urine drainage is very common for some patient groups. The device consists of an indwelling balloon and a catheter tube that reaches from the bladder to a urine-collecting bag mounted on the bedside or on the patient's leg. The function of the balloon is to keep the catheter in place. A significant problem with these catheters is the encrustations and bladder stones that are formed on the balloon in the bladder. Irritation on the bladder and urinary tract infections are common side effects of these devices, still they are frequently used since alternatives are lacking. The cost of indwelling catheters is quite significant due to the integrated design with balloon and catheter in one unit. SUMMARY OF INVENTION [0007] The present invention offers an efficient solution to the problems with the current designs of intra urethral incontinence valves and indwelling catheters. [0008] According to the first aspect of the present invention, it deals with an assembly for controlling emptying of a urine bladder is disclosed. The assembly is adapted to be positioned into a urethra of a female. The assembly comprises an oblong and substantially cylindrically shaped body to be inserted into the urethra. The body presents a urine inlet and a urine outlet, at the ends of the body. The outlets are connected by a through hole extending through the body substantially in the longitudinal direction of the body. The body presents a length being shorter than the length of the urethra. Further, the body presents a length being longer than a cross section of the body. The through hole is able to receive a urine-conducting member, which is projectable through the urine inlet to enter the bladder and may be connected to a urine collecting bag. The assembly further comprises a holder mounted to the outer surface of the body and a plate limiting the movement in the longitudinal direction towards the urine inlet and fixed at the urine outlet, the plate presenting a larger cross section than the body. [0009] The holder is responsive for keeping the assembly in place in the urethra. [0010] The plate that limits the movement in the longitudinal direction towards the urine inlet leads to the advantage of a hindering the assembly from moving too far into the urethra, resulting in that the urine inlet, or even the whole assembly, ends up in the bladder. [0011] That the body presents a length being shorter than the length of the urethra combined with the plate limiting the movement leads to the advantage that the body will not be in contact with the urine in the bladder since it is only the urine-conducting member that will be entered into the bladder. Thus, no part of the assembly is in the bladder. [0012] The length of the female urethra often lies in the interval 35-70 mm, resulting in a length of the body lying in the interval approx. 20-60 mm will open up for a possibility of offering a body that presents a length that will lead to the advantage that the body will not be in the bladder. This decreases the risk of formation of encrustations and stones, etc. on the body, or the assembly, since the contact with urine is limited. The closing function of the bladder neck assists in limiting the contact between urine and the body, or the assembly. In case the length of the urethra is known then an assembly presenting a body having a suitable length may be used. In case the length of the urethra is unknown then an assembly presenting a length that lies in the lower end of the interval 20-60 mm may be used. [0013] That the body presents a length being longer than a cross section of the body results in the advantage that it is easier to insert the assembly into to the female urethra since the there is a decreased risk of tilting the assembly in the urethra when inserting it. There is also a decreased risk of penetrating the urethra wall with the urine-conducting member. [0014] Thus, the present invention includes a body with a holder in the urethra, the body being shorter than the urethra, which minimizes the risk of encrustations on this portion of the device since it is designed in a way that it does not reach into the bladder. [0015] Significant benefits compared with hitherto known designs can be reached since a complete emptying of the bladder can be done but still the risks of encrustations and stone formation is minimal. [0016] In a preferred embodiment, the length of the body is longer than 1.5 times the cross section of the body. This results in the advantage that it is even easier to insert the assembly into to the female urethra since the there is an even more decreased risk of tilting the assembly in the urethra when inserting it. There is also a further decreased risk of penetrating the urethra wall. [0017] In a preferred embodiment, the length of the body is longer than 2 times the cross section of the body. This results in the advantage of an even further ease when inserting the assembly into to the female urethra since the risk of tilting the assembly in the urethra is even more decreased when inserting it. There is also an even further decreased risk of penetrating the urethra wall. [0018] In a preferred embodiment, the outer surface of the body presents an R.sub.A lower than 10. A smooth surface offers the advantage of decreasing the risk for encrustations and bacterial collection on the surface of the body. [0019] In a preferred embodiment, the holder comprises a shape memory compound, or alloy, such as a bi metal or a stent. [0020] Thus an advantage of the assembly is that the body is less likely to accidentally come out the urethra and the plate blocks the body from reaching the bladder. [0021] In a preferred embodiment, the assembly further comprises a removable closing means fixable at the urine outlet. This offers the advantage of being able to close the outlet resulting in decreased risk of leakage. Continue reading... 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